NCT00291902

Brief Summary

Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
Last Updated

June 4, 2012

Status Verified

September 1, 2011

First QC Date

February 13, 2006

Last Update Submit

May 31, 2012

Conditions

Coronary Heart Disease

Keywords

CHDcoronary heart diseaseatherosclerosisinflammation

Outcome Measures

Primary Outcomes (1)

  • Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)

    28 days

Secondary Outcomes (1)

  • Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics

    28 days

Interventions

SB-681323DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females must be of non-child-bearing potential.
  • Female subjects must have a negative pregnancy test.
  • Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography.
  • Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL \<130 mg/dL (3.4 mmol/L) at Screening visit.
  • Must be capable of providing informed consent.
  • Have an hsCRP concentration of \>2 mg/L, but \< 10 mg/L at screening.

You may not qualify if:

  • Women who are pregnant or breast feeding.
  • Planned PCI with multi-vessel stenting.
  • Planned PCI with additional revascularization procedures staged at different days during the study period.
  • Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc).
  • Planned PCI of any bypass graft.
  • History of CABG surgery.
  • Planned cardiac or major non-cardiac surgery within the study period.
  • Disabling stroke in the past 6 months.
  • History of chronic viral hepatitis or other chronic hepatic disorders.
  • History of Gilbert's syndrome or elevated bilirubin concentrations at screening.
  • History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months.
  • Renal impairment with serum creatinine \>2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy.
  • Current inadequately controlled hypertension (blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic) on a stable dose of antihypertensive medication.
  • Current poorly controlled diabetes mellitus, defined as HbA1c \>10% at Screening.
  • History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF\<30%) regardless of symptomatic status.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Esbjerg, 6700, Denmark

Location

GSK Investigational Site

Haderslev, 6100, Denmark

Location

GSK Investigational Site

Hellerup, 2900, Denmark

Location

GSK Investigational Site

Herning, 7400, Denmark

Location

GSK Investigational Site

Viborg, 8800, Denmark

Location

GSK Investigational Site

Bialystok, 15-276, Poland

Location

GSK Investigational Site

Poznan, 60-355, Poland

Location

Related Publications (1)

  • Sarov-Blat L, Morgan JM, Fernandez P, James R, Fang Z, Hurle MR, Baidoo C, Willette RN, Lepore JJ, Jensen SE, Sprecher DL. Inhibition of p38 mitogen-activated protein kinase reduces inflammation after coronary vascular injury in humans. Arterioscler Thromb Vasc Biol. 2010 Nov;30(11):2256-63. doi: 10.1161/ATVBAHA.110.209205. Epub 2010 Aug 5.

    PMID: 20689074DERIVED

MeSH Terms

Conditions

Coronary DiseaseAtherosclerosisInflammation

Interventions

dilmapimod

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 15, 2006

Study Start

March 1, 2006

Last Updated

June 4, 2012

Record last verified: 2011-09

Locations

PL(2)DK(5)